0000000000379083

AUTHOR

T. Göhler

showing 3 related works from this author

Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study.

2016

Abstract Purpose: Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months. Experimental Design: The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014. Results: Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor s…

OncologySorafenibAdultMaleNiacinamideCancer Researchmedicine.medical_specialtyCarcinoma HepatocellularDrug-Related Side Effects and Adverse ReactionsMedizinDisease-Free Survival03 medical and health sciences0302 clinical medicineInternal medicinemedicineHumansAdverse effectProtein Kinase InhibitorsAgedNeoplasm StagingPerformance statusbusiness.industryPhenylurea CompoundsLiver NeoplasmsCancerMiddle AgedSorafenibmedicine.diseasePrognosisSurgeryClinical trialOncology030220 oncology & carcinogenesisHepatocellular carcinomaDisease Progression030211 gastroenterology & hepatologyFemaleLiver functionbusinessLiver cancermedicine.drugClinical cancer research : an official journal of the American Association for Cancer Research
researchProduct

TH-302 + Gemcitabine (G + T) vs Gemcitabine (G) in Patients with Previously Untreated advanced Pancreatic Cancer (PAC)

2012

ABSTRACT Background TH-302 is a hypoxia targeted prodrug with a hypoxia-triggered 2-nitroimidazole component designed to release the DNA alkylator, bromo-isophosphoramide mustard (Br-IPM), when reduced in severe hypoxia. A randomized Phase 2B study (NCT01144455) was conducted to assess the benefit of G + T to standard dose G as first-line therapy of PAC. Materials and methods An open-label multi-center study of two dose levels of TH-302 (240 mg/m2 or 340 mg/m2) in combination with G versus G alone (randomized 1:1:1). G (1000 mg/m2) and T were administered IV over 30-60 minutes on Days 1, 8 and 15 of a 28-day cycle. Patients on the G could crossover after progression and be randomized to a G…

medicine.medical_specialtyGastrointestinal tumorsPerformance statusbusiness.industryHematologySevere hypoxiaNeutropeniamedicine.diseaseRashGastroenterologyDiscontinuationNon colorectalOncologyInternal medicineToxicitymedicinemedicine.symptombusinessAnnals of Oncology
researchProduct

Interim Analysis of Overall Survival Per Subgroups in the Prospective, Non-Interventional Insight Study in Patients with Hepatocellular Carcinoma Tre…

2012

ABSTRACT Background The efficacy of Sorafenib in patients (pts) with hepatocellular carcinoma (HCC) has been proven in randomized, controlled trials. INSIGHT is a prospective, non-interventional study, conducted in Germany and Austria in pts with HCC. The objectives of this study are the evaluation of safety and efficacy under practice conditions in both hospitals and private practices. Enrollment into INSIGHT is not restricted to a particular tumor stage. Recruitment into the study is ongoing. Methods The second interim analysis (data cut-off 23 FEB 2012) evaluated overall survival and safety data in relevant subgroups. All patients with HCC were observed for the duration of their sorafeni…

Sorafenibmedicine.medical_specialtyCirrhosisPerformance statusbusiness.industryHematologymedicine.diseaseInterim analysisBCLC StageOncologyInternal medicineHepatocellular carcinomamedicineStage (cooking)businessAdverse effectmedicine.drugAnnals of Oncology
researchProduct